急性冠状动脉综合征冠状动脉支架术后氯吡格雷联用胃黏膜保护剂的临床观察

Clinical observation of clopidogrel combined with gastric mucosal protective drugs in patients with acute coronary syndrome after percutaneous coronary intervention

目的探讨急性冠状动脉综合征(ACS)患者冠状动脉支架术后不同质子泵抑制剂(PPI)或H2受体拮抗剂(H2RA)与氯吡格雷联用的安全性。方法选取150例成功行冠状动脉支架术的ACS患者,给予双重抗血小板治疗,将受试对象随机分为5组,A1组:埃索美拉唑组(30例);A2组:雷贝拉唑组(30例);B1组:雷尼替丁组(30例);B2组:法莫替丁组(30例)和C组:对照组(30例)。其中A1和A2组统称为PPI组,B1和B2组为H2RA组,至术后30 d继续给予双重抗血小板治疗,所有患者均随访1年,主要终点是不良心血管事件(MACE,包括心原性死亡、非致死性急性心肌梗死、紧急靶血管血运重建、亚急性支架内血栓、脑卒中),次要终点是出血事件。结果 5组的临床基本资料差异无统计学意义;与对照组(6.9%)比较,PPI组、H2RA组1年内累积MACE发生率分别为5.36%、3.45%,3组间MACE发生率相近(HR:0.91,95%CI:0.17～4.88;HR:2.17,95%CI:0.27～17.42,P=0.915、0.467);与A1组(3.7%)比较,A2组MACE发生率为6.9%(HR:0.60,95%CI:0.08～4.70,P=0.629),与B1组(6.7%)比较,B2组为0(HR:0.14,95%CI:0.01～2.32,P=0.172)。所有患者均未发生严重出血;与对照组(10.34%)比较,PPI组、H2RA组1年内累积轻微出血发生率分别为12.5%、10.34%(HR:0.80,95%CI:0.22～2.96;HR:0.97,95%CI:0.24～3.86,P=0.734、0.964);与A1组(11.11%)比较,A2组轻微出血发生率为13.79%(HR:0.81,95%CI:0.18～3.59,P=0.769),与B1组(6.67%)比较,B2组为14.29%(HR:0.46,95%CI:0.09～2.27,P=0.366)。结论冠状动脉支架术后不同PPI或H2RA与氯吡格雷联用不增加1年内MACE与出血发生率。

Objective To investigate the safety of different proton pump inhibitors （PPI） combined with clopidogrel in patients with acute coronary syndrome underwent percutaneous coronary intervention （PCI）. Methods A total of 150 patients with ACS were selected and received dual anti - platelet treatment after PCI. The subjects were randomly assigned to five groups （30 in each group） ： group A1 ： esomeprazole; group A2： rabeprazole; group BI： ranitidine; group B2： famotidine; group C： control group. Groups A1 and A2 were called group PPI, and group B1 and B2 were named group H2RA. They continued to be given double anti - platelet therapy for 30 days after PCI. All of the patients were followed up for cardiac death, nonfatal myocardial infarction （MI）, urgent target vessel revascularization （UTVR）, sub-cute in-stent thrombosis （SAT） and stroke, and secondary of end point was the incidence of bleeding. Results No significant difference existed among the five groups in baseline data. Compared with control group （6. 9% ）, the rates of MACE in group PPI and H2RA in a year were 5.36% and 3.45% , respectively. No significant difference was found among the three groups （HR： 0. 91,95% CI： 0. 17 -4. 88;HR： 2. 17, 95% CI： 0. 27-17.42, P=0.915, 0.467）. The rates of MACE were 3.7% , 6.9% （HR： 0.60, 95% CI： 0.08 -4.7, P=0.629）, 6.7%,0% （HR：0.14,95% CI. 0.01-2.32, P=0.172） ingroupA1, A2, B1, andB2, respectively. There was no hemorrhage in all groups. Compared with control group （ 10. 34% ）, the rates of minor bleeding events in group PPI and H2RA in a year were 12. 5% ,10. 34% （HR： 0. 80, 95% CI：0. 22 -2. 96; HR： 0. 97, 95% CI： 0. 24 -3.86, P =0. 734, 0. 964）, respectively. The rates of minor bleeding events were 11.11%, 13.79% （HR： 0.81, 95%CI： 0.18-3.59, P〉0.05）, 6. 67% and 14. 29% （ HR ： 0.46, 95% CI： 0. 09 - 2. 27, P = 0. 769） in group A1, A2, B1 and B2, respectively. There were no significant difference of minor bleeding events among all the groups （P = 0. 366）. Conclusions Different PPI or H2RA combined with clopidogrel for patients undergone PCI can significantly decrease the incidence of MACE and hemorrhagic complications within a year.